EMEA-002969-PIP01-21 - paediatric investigation plan

Zibotentan

dapagliflozin propanediol monohydrate

Key facts

• Active Substance:
  • Zibotentan
  • dapagliflozin propanediol monohydrate
• Therapeutic area:
  Other
• Decision number:
  P/0249/2021
• PIP number:
  EMEA-002969-PIP01-21
• Pharmaceutical form(s):
  • Capsule, hard
  • Tablet
• Condition(s) / indication(s):
  Treatment of chronic kidney disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/07/2021

Decision

P/0249/2021: EMA decision of 9 July 2021 on the granting of a product specific waiver for zibotentan / dapagliflozin (propanediol monohydrate), (EMEA-002969-PIP01-21)

Reference Number: EMA/360235/2021